Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CMK389 · 2 trials · 2 indications
The Investigator Global assessment (IGA) scale used was vIGA-AD\^TM (Validated Investigator Global Assessment scale for Atopic Dermatitis). The IGA rating scale was used to determine the severity of atopic dermatitis and clinical response to treatment. It reflected a participant's overall disease severity for the whole body based on a 5-point scale. The 5-point scale included: clear, almost clear, mild, moderate, and severe disease. IGA response is defined as clear or almost clear and at least a 2 point-reduction from baseline at week 16.
To assess the effect of CMK389 compared to placebo after 16 weeks of treatment on spirometry (Forced Vital Capacity). Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Percent predicted FVC is the percentage of the age, height and gender adjusted predicted value.
| Arm | Type | Description |
|---|---|---|
| CMK389 10mg/kg i.v. | EXPERIMENTAL | Active |
| Placebo i.v. | PLACEBO_COMPARATOR | Placebo |
| CMK389 300mg s.c. | EXPERIMENTAL | Active |
| Placebo s.c. | PLACEBO_COMPARATOR | Placebo |
| CMK389 | EXPERIMENTAL | CMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses |
| Placebo | PLACEBO_COMPARATOR | Placebo i.v. every 4 weeks for a total of 4 doses |
| Name | Type | Description |
|---|---|---|
| CMK389 | BIOLOGICAL | Active |
| Placebo | BIOLOGICAL | Placebo Comparator |
Inclusion Criteria: * Adult male or female participants with chronic atopic dermatitis, aged 18 to 65 years, present for at least 1 year before screening. * Participants with Moderate to severe AD defined by IGA score of ≥ 3 (on a scale of 0 to 4, in which 3 is moderate and 4 is severe) at Baseline...
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CMK389 is an investigational monoclonal antibody being studied for the treatment of chronic pulmonary sarcoidosis and moderate to severe atopic dermatitis. It is being developed by Novartis AG (NVS) and is currently in Phase 2 clinical development for both indications.
CMK389 is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being investigated for its potential role in treating inflammatory conditions such as pulmonary sarcoidosis and atopic dermatitis, though the exact mechanism of action is not publicly detailed.
CMK389 is being developed by Novartis AG, a global healthcare company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the drug's safety and efficacy in patients with pulmonary sarcoidosis and atopic dermatitis.
CMK389 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one in chronic pulmonary sarcoidosis and another in moderate to severe atopic dermatitis. The drug is not yet approved and remains investigational.
CMK389 has been studied in two completed Phase 2 trials. NCT04064242 evaluated the drug in 62 patients with chronic pulmonary sarcoidosis across the US, Czechia, Denmark, Germany, Poland, and the UK. NCT04836858 assessed it in 71 patients with moderate to severe atopic dermatitis in several European countries.
CMK389 is the sole name provided for this investigational drug. No alternative names or brand names have been associated with it in the available clinical trial information. It is identified only as CMK389 in the studies conducted by Novartis.